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Recall Observatory FDA recall evidence

Drug product

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

D-1296-2020

April 20, 2020

Class I

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 85504
Status
Terminated
Classification
Class I
Quantity
5,314,400 vials
Official record key
drug-enforcement:D-1296-2020

Official wording

Reason: Presence of Particulate Matter - found in reserve sample vials at the firm.

Code information: Lot #: 6118737, 6118902, Exp 04/2020; 6119052, Exp 05/2020; 6119752, Exp 08/2020; 6122349, Exp 07/2021; 6122538, Exp 09/2021

Distribution pattern: USA Nationwide and Puerto Rico

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter